The purpose of this study is to determine the effectiveness of a stress management group intervention for people with HIV. The study will evaluate several outcomes, including perceived stress, quality of life, psychosocial factors, and physiological measures of stress.

Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

Primary Outcome Measures:

Intrusive Thoughts

Perceived Stress

Trait Anxiety

Trait Anger

Secondary Outcome Measures:

Spiritual Well-Being (FACIT-SpEx)

Quality of Life Enjoyment and Satisfaction

Ways of Coping

Urinary cortisol levels

Urinary catecholamines

Salivary cortisol levels

Estimated Enrollment:

60

Study Start Date:

May 2003

Estimated Study Completion Date:

May 2003

Detailed Description:

It is well documented that living with HIV/AIDS can cause a great amount of stress, and evidence suggests that stress may hasten HIV disease progression by increasing viral replication and suppressing the immune response. Stress management intervention studies using more complex combinations of cognitive and relaxation therapies have shown improvements in both psychological and physiological measures in HIV infected persons. However, no studies have focused on only one intervention or have addressed the spiritual component using a comparable control group to determine which of these interventions is most effective.

Participants will be randomly assigned to receive either a spiritually-based cognitive intervention to an educational control group. The intervention will be given over a 10-week period, with 5 weekly classes, 4 weekly automated phone calls, and one final class meeting. Assessments will be conducted at pre-intervention, fifth class midpoint, tenth week post-intervention, and 3-month follow-up. Time commitment can vary from 6 months to 9 months, depending on when participants are screened.

Eligibility

Ages Eligible for Study:

18 Years to 65 Years (Adult)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

HIV infected for at least 6 months

Ability to read and write English

Exclusion Criteria:

Drug use within the past 6 months

Cognitive impairment or dementia

Diagnosis that may affect cortisol levels, such as diabetes, cancer, or asthma

Loss of family/loved one in past 3 months

Started a relaxation therapy in past 3 months

History or current practice of the RISE program, rosary, chanting, or Transcendental Meditation (TM)

Acute infection in past month

Change of HAART or drug regimen in past month

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057538